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The Machinery Directive 2006/42/EC Aims of the Machinery Directive 2006/42/EC • To ensure the free movement of machinery on the EU market whether manufactured in the EU or imported • To ensure a high level of protection of users of machinery (workers and consumers) and other exposed persons • To ensure safety by design Scope: the basic definition of Machinery (a) “An assembly, fitted with or intended to be fitted with a drive system other than directly applied human effort, consisting of linked parts and components, at least one of which moves, and which are joined together for a specific application” Machinery also includes: • Assemblies missing only components for connexion to the energy supply • Assemblies to be mounted on a means of transport or a building • Assemblies of machinery that function as an integral whole • Manually powered lifting machinery Other products in the scope designated by “Machinery” (b) (c) (d) (e) (f) Interchangeable equipment Safety components (indicative list in Annex V) Lifting accessories Chains ropes and webbing for lifting purposes Removable mechanical transmission devices (PTO shafts) Partly completed machinery (PCM) • Almost machinery – lacking some elements in order to function • Cannot perform a specific application • Intended to be incorporated with other machinery, other PCMs or other equipment to form final machinery • Subject to a specific procedure Not subject to the Directive as such • Machinery components other than safety components • Sub-assembles that are not PCMs • The machinery manufacturer must choose components and subassemblies that enable the machinery to comply with the Directive Excluded from the scope • Fairground equipment • Machinery for nuclear purposes • Weapons • Tractors, road vehicles, ships • Temporary research machinery • Machinery for police or military purposes (continue) Exclusions (continued) • Certain categories of low voltage electrical machinery - household appliances for domestic use - audio and video equipment - information technology equipment - ordinary office machinery - circuit-breakers and switches - electric motors • High voltage switch and control gear and transformers When the Directive applies • The Directive applies to machinery when it is first placed on the EU market = when it is first made available for distribution or use • Applies to new machinery manufactured in the EU and new or used machinery imported from outside the EU Obligations of machinery manufacturers • Make a risk assessment • Apply the relevant essential health and safety requirements • Constitute a technical file • Carry out a conformity assessment • Draw up and sign an EC Declaration of Conformity • Affix the CE marking Obligations of manufacturers of partly completed machinery • Draw up and sign a Declaration of Incorporation • State which essential health and safety requirement have been fulfilled • Constitute the relevant technical documentation • Provide assembly instructions to the manufacturer of the final machinery Authorised representative • The manufacturer may entrust an authorised representative established in the EU with all or part of his obligations • It is not mandatory to have an authorised representative in the EU • It is mandatory to nominate a contact person in the EU for the technical file Annex I - Essential Health and Safety Requirements (EHSRs) 1. General principles and requirements for all machinery 2. Foodstuffs, portable hand-held and woodworking machinery 3. Mobility of machinery 4. Lifting operations 5. Underground machinery 6. Machinery for lifting persons Application of EHSRs • • • Based on the risk assessment Taking account of the state of the art Principles of safety integration Order of priority: 1. Inherently safe design measures 2. Technical protective measures 3. Warnings, signs and instructions Harmonised Standards • EHSRs are mandatory when the risk exists • The EHSRs are supported by the technical specifications of European Harmonised Standards • Harmonised Standards are voluntary • Their application confers a presumption of conformity to the EHSRs they cover A, B and C-type standards • A-type standards - methodology • B-type standards - common safety solutions • C-type standards - particular categories of machinery C-type standards take precedence Conformity assessment procedures • Most categories of machinery (not listed in Annex IV) are subject to the procedure for assessment of conformity with internal checks on manufacture • For these categories there is no need for third-party conformity assessment Machinery listed in Annex IV • • If the machinery complies with Harmonised Standard(s) that cover all the applicable EHSRs - Internal checks If not - EC type-examination by a Notified Body or - Approval of full quality assurance Notified Bodies • Manufacturers can address any Notified Body that is competent for the category of machinery and the procedure concerned • EC type-examination certificates or approvals of full quality assurance systems are valid throughout the EU Enforcement - market surveillance • The Member States are responsible for enforcement – Market surveillance • Manufacturers may be required to bring their products into conformity • Unsafe products must be removed from the market • Customs can check the conformity of products entering the EU Directive 2006/42/EC: date of application • The revised Machinery Directive has been applicable since 29 December 2009 • Machinery placed on the market before 29 December 2009 is subject to Directive 98/37/EC Guide to application • The 1st Edition of the Guide to application of the Machinery Directive 2006/42/EC published on the European Commission Website EUROPA • Not legally binding but intended to ensure uniform interpretation • The Guide will be completed in 2010 Further information Machinery website on EUROPA: http://ec.europa.eu/enterprise/sectors/mechanical/machinery Contact points: [email protected] [email protected] Thanks for your attention!